MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 20GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386863
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd us cathena 20gx1.25in straight bc safety shield activation failed.It was reported by customer that some of our iv cathena products are having issues with their safety mechanism not retracting.Is this a known issue? this event occurred (b)(6)2025 with one of our nurses.I do have the product in my office if needed for a return.If you have anymore questions, please let me know.Verbatim: please advise - it was reported that some of our iv cathena products are having issues with their safety mechanism not retracting.Is this a known issue? this event occurred (b)(6)2025 with one of our nurses.I do have the product in my office if needed for a return.If you have anymore questions, please let me know.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of safety shield activation failure was not confirmed upon inspection of the sample.Analysis of the sample showed that the safety mechanism was not fully activated.No dent was observed on the cannula and no damage was observed on the v-clip and washer components.The safety mechanism of the sample was manually activated by manually pushing the tip shield fully through the cannula.No safety activation failure was observed as the tip shield was able to be pulled forward to cover the sharp cannula tip.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.The root cause could not be determined as the defect was not replicated.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
Material# 386863.Batch# 4218594.It was reported by customer that some of our iv cathena products are having issues with their safety mechanism not retracting.Is this a known issue? this event occurred 1/8/2025 with one of our nurses.I do have the product in my office if needed for a return.If you have anymore questions, please let me know.

• Brand Name: BD US CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21284365
• Report Number: 2243072-2025-00034
• Device Sequence Number: 9355773
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636(11)240815(17)270731(10)4218594
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 386863
• Device Lot Number: 4218594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown